Earlier this week, Elizabeth Holmes did something unusual. The normally cryptic founder and C.E.O. of Theranos, the embattled blood-testing start-up once valued at $9 billion, presented data on the state of her company’s technology to the scientific community. And from appearances, members of the scientific community were eager to hear what she had to say. At the annual meeting of the American Association for Clinical Chemistry, in Philadelphia, Holmes addressed a room filled with some 2,500 people, not including two separate overflow rooms, where attendees watched her presentation via a live feed.

Instead, much of her 60-minute speech focused on the introduction of Theranos’s new diagnostic tool, dubbed the miniLab, a tabletop-size box intended to perform multiple diagnostic tests on small samples of blood. But despite the efforts of the 32-year-old founder, the presentation was greeted with skepticism. Dr. Stephen Master, an associate professor of pathology and clinical medicine at Weill Cornell Medical College, and one of the experts chosen to question Holmes during the Q&A portion of the presentation, noted that her findings “fell far short” of her previous claims.

The Hive spoke with Dr. Master about what went wrong at Theranos, his takeaways from Holmes’s address, and how the company can attempt to earn back the trust of the scientific community.

The Hive: On Monday, following her presentation, a number of outlets quoted you as telling Holmes that the evidence she presented “fell far short” of her previous claims. What prompted you to say that?

Dr. Stephen Master: I think a lot of the interest in Theranos—certainly on my part, and I think for a number of my colleagues—came from the fact that they claimed they could do the full complement of laboratory tests from a few drops of blood. What they showed fell far short of that. They did not claim in the talk that they could do that, but certainly they had claimed that regularly in the past. They showed us a limited set of four tests on one set of subjects and another limited set of tests on another set of subjects. By itself, it didn’t match all of the claims that they had previously made.

[In a statement, Theranos responded that the results it presented at the A.A.C.C. conference “were not intended to reflect all the tests Theranos has developed for its various platforms. The presentation marked the introduction of Theranos’s technology architecture and key inventions, and is being followed by submissions for peer review, including on different assays, and continued focus on F.D.A. filings.”]

What were your takeaways from Holmes’s presentation of the Theranos data? Was it what you were expecting?

Although I am not sure, it is not clear to me how different Edison [Theranos’s previous, embattled technology] and miniLab are. But in terms of what I was expecting versus what I saw, what I saw was an attempt to integrate a number of different kinds of analyzers into one box and to do it in a way that could accommodate small samples. The problem is that they showed us a limited number of tests, and I think we had a right to expect—based on what they had said previously—that they would be able to show a very large number of tests on a single drop of blood. We did not see that.

In terms of the data, I think a number of people had trouble with the fact that, after an incident like that, they didn’t have an independent third party test the technology. I think a lot people were skeptical about the data that was shown, but I would have to say that there was nothing that they showed in the data that made me say, “Oh, I don’t think that’s real.”

When Theranos first launched, it gained notoriety because of the promises it made. Would you say that what you saw during Holmes’s presentation wasn’t nearly as innovative of a technology as what the company originally came out of the gate with?

Well, you know, it is hard to actually say what they came out of the gate with because they had never told us what it was, exactly, that they were doing. But let’s look at it this way: if they had not made any of the previous claims, and the first time that we had heard about Theranos was Monday, and they came in and they gave that presentation, then I think that I would look at that and say, “It looks like there is good engineering in that box,” or, “This looks like a natural extension of what others are doing.” And if I had a need for a device like that I would certainly evaluate it alongside other metrics.

“Combining a culture of secrecy with a lack of appreciation of proper
lab procedure meant that Theranos was particularly vulnerable when
they had technical problems.”

I don’t think that anyone will look at it and say, “Oh, they have nothing.” They have something. But what they have isn’t as revolutionary as what they claimed, and that is the big issue. They wouldn’t have had a packed room of that size if they hadn’t made their expansive claims. But you can’t get the benefit of people coming for those claims, and then say, “Oh, we are going to focus on what we are actually doing and working on today.”

When did you first learn about Theranos and what was your first impression?

It was from an article in the popular press; it must’ve been Wired or something like that, and I just remember reading about the things that they said that they could do—this large number of tests on finger-stick samples—and my initial impression was if that is right, it would be a game changer. At face value, I thought it was very exciting. But what ended up happening is that it became very clear that they did not intend to publish anything. It was very much like, “We are going to change the world, but we are not going to tell you what we are doing.” At a certain point, people just wanted somebody to stand up with data to prove that this worked, and it became clearer and clearer that that wasn’t going to happen.

[“This presentation was the beginning of a new chapter,” Theranos said in response. “We are building on that presentation in sharing our work and data with the scientific community, including submissions to peer-review journals, initiating studies with independent third parties, and continuing work towards F.D.A. submissions for clearance of our assays.”]

In your opinion, is there one thing that you could point to as the reason Theranos found itself in its current situation?

I think part of it was a culture of secrecy and I think, in retrospect, we can say part of it was a lack of appropriate understanding of what the standards of a clinical lab are and how it has to be run. That was a particularly bad combination, and I think it really created the problem.

The issue is that the lab-medicine community works through a series of checks and balances. Labs check out what vendors say and labs run their own tests and then inspectors check what those labs have done. I think that combining a culture of secrecy with a lack of appreciation of proper lab procedure meant that Theranos was particularly vulnerable when they had technical problems. It created a situation that didn’t allow those checks and balances to function appropriately.

[Theranos told the Hive it is “dedicated to excellence in laboratory operations, and has expanded its leadership team, Board of Directors, and Scientific and Medical Advisory Board with experts to help it continually build and implement best-in-class procedures.”]

After the Centers for Medicare and Medicaid Services revealed what was going on behind the scenes at Theranos, how did it hit the scientific community?

How this hit the scientific community is hard to generalize entirely. But the laboratory-medicine community takes patient care very, very seriously, and a large part of our job, particularly on the clinical side, is precisely making sure that we run laboratories that follow the regulations, that are safe, that deliver—as clichéd as it sounds—quality patient results.

I think that the deficiencies that were documented in the case of Theranos were not even just limited to their technology. There were all sorts of deficiencies in that report, and that was really just a top-to-bottom indictment of a group that did not know how to run a clinical lab correctly, or certainly wasn’t doing it if they did know. Now within that report, there were indications that suggested that the technology was not performing in an acceptable way, and, I think from that standpoint, it also raised a number of scientific questions as to their capability to do what they said they were doing.

Looking ahead, what do you think Theranos needs to do if they ever want to gain back the trust of the scientific community and the public at large?

Following through on their promises to publish in the peer-reviewed literature and to have other groups evaluate their technology are clearly steps in the right direction. I do think that they have to do that. Obviously, I can’t say that if I were Theranos, that I would say that I have a tainted brand; they are going to have some challenges to overcome, and I think that if they were able to overcome them, then the way that they would do that is by not overselling what they have. I think that they have ripped the Band-Aid off. Now people know what they have, and if they do not make any overblown claims and only explain what it is that they are showing, my guess is that the scientific community will evaluate them as they would any other vendor.

But the difference is that up until now, Theranos made such wide claims about their ability from a technical perspective that when it turns out that they didn’t present evidence to back that up, there was certainly something of a backlash. So the only way forward would be for them to do it the patient way, and actually convince people with data, step by step.

Theranos did bill itself as a technology company. Are there any lessons that you think investors and Silicon Valley can learn from what went wrong at the start-up?

There is the sort of obvious one, which is: when you are dealing with patients, the bar is set higher.